Shire resubmitted its application for the drug to the FDA with additional data after the regulator informed the company in December 2005 via an approvable letter that it would need more information before it could approve the drug. The FDA now has 60 days to complete its review of the resubmission.
The concerns that the FDA raised in its approvable letter for the drug centered on proposed revisions to labeling, as well as requests for data clarification, post-marketing surveillance, and post-marketing studies.
Daytrana, licensed globally from Noven Pharmaceuticals, is a developmental product for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years.
If Daytrana is ultimately approved, Noven would be entitled to receive a $50 million milestone payment from Shire, and would have the opportunity to earn additional milestone payments of up to $75 million depending on the level of Shire’s commercial sales of the product. In addition, Noven expects to earn a profit on the manufacture and supply of finished product to Shire.